Research ethics guidelines do not provide sufficient direction for breastfeeding and human lactation studies. This article presents the principles of consent for research studies and discusses rationales for who should consent for infants in lactation and breastfeeding research studies.
World Health Organization.Research Ethics. Available at: http://www.who.int/rpc/research_ethics/en/index.html. Accessed December 7, 2009.
2.
Interagency Advisory Panel on Research Ethics (PRE).Tri-council Policy Statement: Ethical Conduct for Research Involving Humans. Available at: http://pre.ethics.gc.ca/eng/policy-politique/tcps-eptc/ . Accessed February 3, 2010.
3.
Department of Health.Research Governance Framework for Health and Social Care [2nd ed.; 2005]. Available at: http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4122427.pdf . Accessed December 7, 2009.
4.
US Department of Health and Human Resources.Code of Federal Regulations: Title 45 - Public Welfare, Part 46 - Protection of Human Subjects (2005 ). Available at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Accessed December 7, 2009.
5.
National Health and Medical Research Council , Australian Research Council, and Australian Vice-Chancellors’ Committee. National Statement on Ethical Conduct in Human Research (2007). Available at: http://www.nhmrc.gov.au/_files_nhmrc/file/publications/synopses/e72-jul09.pdf. Accessed December 22, 2009.
6.
Mason SA, Allmark PJObtaining informed consent to neonatal randomised controlled trials: interviews with parents and clinicians in the Euricon study. Lancet. 2000;356:2045-2051.